Amended IN Assembly May 30, 2017 Amended IN Assembly May 10, 2017 Amended IN Assembly April 26, 2017 Amended IN Assembly March 27, 2017 CALIFORNIA LEGISLATURE 20172018 REGULAR SESSION Assembly Bill No. 265Introduced by Assembly Member Wood(Coauthor: Assembly Member Chiu)January 31, 2017 An act to add Article 7 (commencing with Section 111657) to Chapter 6 of Part 5 of Division 104 of the Health and Safety Code, relating to public health. LEGISLATIVE COUNSEL'S DIGESTAB 265, as amended, Wood. Prescription drugs: prohibition on price discount. (1) The Sherman Food, Drug, and Cosmetic Law regulates the packaging, labeling, and advertising of drugs and devices, and is administered by the State Department of Public Health. The law makes a violation of its provisions a crime.This bill would expand the law to prohibit, except as provided, a person who manufactures a prescription drug from offering in California any discount, repayment, product voucher, or other reduction in an individuals out-of-pocket expenses associated with his or her insurance coverage, including, but not limited to, a copayment, coinsurance, or deductible, for any prescription drug if a lower cost generic drug is covered under the individuals health plan on a lower cost-sharing tier that is designated as therapeutically equivalent to, or interchangeable with, the prescription drug manufactured by that person or if the active ingredients of the drug are available without prescription at a lower cost and are not otherwise contraindicated for the condition for which the prescription drug is approved. The bill would provide that the department shall enforce a violation of these provisions only upon receipt of a complaint that alleges the violation.By expanding the scope of a crime, this bill would impose a state-mandated local program.(2) The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.This bill would provide that no reimbursement is required by this act for a specified reason.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: YES Bill TextThe people of the State of California do enact as follows:SECTION 1. Article 7 (commencing with Section 111657) is added to Chapter 6 of Part 5 of Division 104 of the Health and Safety Code, to read: Article 7. Prescription Drug Discount Prohibition111657. Except as provided in Section 111657.5, a person who manufactures a prescription drug shall not offer in the state a discount, repayment, product voucher, or other reduction in an individuals out-of-pocket expenses associated with his or her insurance coverage, including, but not limited to, a copayment, coinsurance, or deductible, for a prescription drug if a lower cost generic drug is covered under the individuals health plan on a lower cost-sharing tier that is designated to be therapeutically equivalent as indicated by the United States Food and Drug Administrations Approved Drug and Products with Therapeutic Equivalence Evaluations.111657.1. Except as provided in Section 111657.5, a person who manufactures a prescription drug shall not offer in the state a discount, repayment, product voucher, or other reduction in the individuals out-of-pocket expenses associated with his or her insurance coverage, including, but not limited to, a copayment, coinsurance, or deductible, for a prescription drug if the active ingredients of the drug are available without prescription at a lower cost and are not otherwise contraindicated for treatment of the condition for which the prescription drug is approved.111657.5. The prohibitions in Sections 111657 and 111657.1 shall not apply to any of the following:(a) A discount, repayment, product voucher, or other payment to a patient or another person on the patients behalf for a prescription drug required under a United States Food and Drug Administration Risk Evaluation and Mitigation Strategy for the purpose of monitoring or facilitating the use of that prescription drug in a manner consistent with the approved labeling of the prescription drug.(b) A single-tablet drug regimen for treatment or prevention of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) that is as effective as a multitablet regimen, unless, consistent with clinical guidelines and peer-reviewed scientific and medical literature, the multitablet regimen is clinically equally effective or more effective and is more likely to result in adherence to the drug regimen.(c) Rebates received by a state agency.111657.7. This article does not prohibit an entity, including an entity that manufactures prescription drugs, from offering pharmaceutical products free of any cost to both patients and insurers.111657.10. (a) This article shall not be deemed to affect a pharmacists ability to substitute a prescription drug pursuant to Section 4073 of the Business and Professions Code.(b) (1) This article shall not prohibit or limit assistance to a patient provided by an independent charity patient assistance program.(2) For purposes of this section, independent charity patient assistance program means a program that meets all of the following requirements:(A) The program does not allow a pharmaceutical manufacturer or an affiliate of the manufacturer, including, but not limited to, an employee, agent, officer, shareholder, contractor, wholesaler, distributor, or pharmacy benefits manager, to exert any direct or indirect influence or control over the charity or subsidy program.(B) Assistance is awarded in a truly independent manner that severs any link between a pharmaceutical manufacturers funding and the beneficiary.(C) Assistance is awarded without regard to the pharmaceutical manufacturers interest and without regard to the beneficiarys choice of product, provider, practitioner, supplier, or insurance plan.(D) Assistance is awarded based upon a reasonable, verifiable, and uniform measure of financial need that is applied in a consistent manner.(E) The pharmaceutical manufacturer does not solicit or receive data from the program that would facilitate the manufacturer in correlating the amount or frequency of its donations with the number of subsidized prescriptions for its products.111657.12. The department shall enforce a violation of this article only upon receipt of a complaint that alleges that violation.SEC. 2. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
Amended IN Assembly May 30, 2017 Amended IN Assembly May 10, 2017 Amended IN Assembly April 26, 2017 Amended IN Assembly March 27, 2017 CALIFORNIA LEGISLATURE 20172018 REGULAR SESSION Assembly Bill No. 265Introduced by Assembly Member Wood(Coauthor: Assembly Member Chiu)January 31, 2017 An act to add Article 7 (commencing with Section 111657) to Chapter 6 of Part 5 of Division 104 of the Health and Safety Code, relating to public health. LEGISLATIVE COUNSEL'S DIGESTAB 265, as amended, Wood. Prescription drugs: prohibition on price discount. (1) The Sherman Food, Drug, and Cosmetic Law regulates the packaging, labeling, and advertising of drugs and devices, and is administered by the State Department of Public Health. The law makes a violation of its provisions a crime.This bill would expand the law to prohibit, except as provided, a person who manufactures a prescription drug from offering in California any discount, repayment, product voucher, or other reduction in an individuals out-of-pocket expenses associated with his or her insurance coverage, including, but not limited to, a copayment, coinsurance, or deductible, for any prescription drug if a lower cost generic drug is covered under the individuals health plan on a lower cost-sharing tier that is designated as therapeutically equivalent to, or interchangeable with, the prescription drug manufactured by that person or if the active ingredients of the drug are available without prescription at a lower cost and are not otherwise contraindicated for the condition for which the prescription drug is approved. The bill would provide that the department shall enforce a violation of these provisions only upon receipt of a complaint that alleges the violation.By expanding the scope of a crime, this bill would impose a state-mandated local program.(2) The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.This bill would provide that no reimbursement is required by this act for a specified reason.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: YES
Amended IN Assembly May 30, 2017 Amended IN Assembly May 10, 2017 Amended IN Assembly April 26, 2017 Amended IN Assembly March 27, 2017
Amended IN Assembly May 30, 2017
Amended IN Assembly May 10, 2017
Amended IN Assembly April 26, 2017
Amended IN Assembly March 27, 2017
CALIFORNIA LEGISLATURE 20172018 REGULAR SESSION
Assembly Bill No. 265
Introduced by Assembly Member Wood(Coauthor: Assembly Member Chiu)January 31, 2017
Introduced by Assembly Member Wood(Coauthor: Assembly Member Chiu)
January 31, 2017
An act to add Article 7 (commencing with Section 111657) to Chapter 6 of Part 5 of Division 104 of the Health and Safety Code, relating to public health.
LEGISLATIVE COUNSEL'S DIGEST
## LEGISLATIVE COUNSEL'S DIGEST
AB 265, as amended, Wood. Prescription drugs: prohibition on price discount.
(1) The Sherman Food, Drug, and Cosmetic Law regulates the packaging, labeling, and advertising of drugs and devices, and is administered by the State Department of Public Health. The law makes a violation of its provisions a crime.This bill would expand the law to prohibit, except as provided, a person who manufactures a prescription drug from offering in California any discount, repayment, product voucher, or other reduction in an individuals out-of-pocket expenses associated with his or her insurance coverage, including, but not limited to, a copayment, coinsurance, or deductible, for any prescription drug if a lower cost generic drug is covered under the individuals health plan on a lower cost-sharing tier that is designated as therapeutically equivalent to, or interchangeable with, the prescription drug manufactured by that person or if the active ingredients of the drug are available without prescription at a lower cost and are not otherwise contraindicated for the condition for which the prescription drug is approved. The bill would provide that the department shall enforce a violation of these provisions only upon receipt of a complaint that alleges the violation.By expanding the scope of a crime, this bill would impose a state-mandated local program.(2) The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.This bill would provide that no reimbursement is required by this act for a specified reason.
(1) The Sherman Food, Drug, and Cosmetic Law regulates the packaging, labeling, and advertising of drugs and devices, and is administered by the State Department of Public Health. The law makes a violation of its provisions a crime.
This bill would expand the law to prohibit, except as provided, a person who manufactures a prescription drug from offering in California any discount, repayment, product voucher, or other reduction in an individuals out-of-pocket expenses associated with his or her insurance coverage, including, but not limited to, a copayment, coinsurance, or deductible, for any prescription drug if a lower cost generic drug is covered under the individuals health plan on a lower cost-sharing tier that is designated as therapeutically equivalent to, or interchangeable with, the prescription drug manufactured by that person or if the active ingredients of the drug are available without prescription at a lower cost and are not otherwise contraindicated for the condition for which the prescription drug is approved. The bill would provide that the department shall enforce a violation of these provisions only upon receipt of a complaint that alleges the violation.
By expanding the scope of a crime, this bill would impose a state-mandated local program.
(2) The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
## Digest Key
## Bill Text
The people of the State of California do enact as follows:SECTION 1. Article 7 (commencing with Section 111657) is added to Chapter 6 of Part 5 of Division 104 of the Health and Safety Code, to read: Article 7. Prescription Drug Discount Prohibition111657. Except as provided in Section 111657.5, a person who manufactures a prescription drug shall not offer in the state a discount, repayment, product voucher, or other reduction in an individuals out-of-pocket expenses associated with his or her insurance coverage, including, but not limited to, a copayment, coinsurance, or deductible, for a prescription drug if a lower cost generic drug is covered under the individuals health plan on a lower cost-sharing tier that is designated to be therapeutically equivalent as indicated by the United States Food and Drug Administrations Approved Drug and Products with Therapeutic Equivalence Evaluations.111657.1. Except as provided in Section 111657.5, a person who manufactures a prescription drug shall not offer in the state a discount, repayment, product voucher, or other reduction in the individuals out-of-pocket expenses associated with his or her insurance coverage, including, but not limited to, a copayment, coinsurance, or deductible, for a prescription drug if the active ingredients of the drug are available without prescription at a lower cost and are not otherwise contraindicated for treatment of the condition for which the prescription drug is approved.111657.5. The prohibitions in Sections 111657 and 111657.1 shall not apply to any of the following:(a) A discount, repayment, product voucher, or other payment to a patient or another person on the patients behalf for a prescription drug required under a United States Food and Drug Administration Risk Evaluation and Mitigation Strategy for the purpose of monitoring or facilitating the use of that prescription drug in a manner consistent with the approved labeling of the prescription drug.(b) A single-tablet drug regimen for treatment or prevention of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) that is as effective as a multitablet regimen, unless, consistent with clinical guidelines and peer-reviewed scientific and medical literature, the multitablet regimen is clinically equally effective or more effective and is more likely to result in adherence to the drug regimen.(c) Rebates received by a state agency.111657.7. This article does not prohibit an entity, including an entity that manufactures prescription drugs, from offering pharmaceutical products free of any cost to both patients and insurers.111657.10. (a) This article shall not be deemed to affect a pharmacists ability to substitute a prescription drug pursuant to Section 4073 of the Business and Professions Code.(b) (1) This article shall not prohibit or limit assistance to a patient provided by an independent charity patient assistance program.(2) For purposes of this section, independent charity patient assistance program means a program that meets all of the following requirements:(A) The program does not allow a pharmaceutical manufacturer or an affiliate of the manufacturer, including, but not limited to, an employee, agent, officer, shareholder, contractor, wholesaler, distributor, or pharmacy benefits manager, to exert any direct or indirect influence or control over the charity or subsidy program.(B) Assistance is awarded in a truly independent manner that severs any link between a pharmaceutical manufacturers funding and the beneficiary.(C) Assistance is awarded without regard to the pharmaceutical manufacturers interest and without regard to the beneficiarys choice of product, provider, practitioner, supplier, or insurance plan.(D) Assistance is awarded based upon a reasonable, verifiable, and uniform measure of financial need that is applied in a consistent manner.(E) The pharmaceutical manufacturer does not solicit or receive data from the program that would facilitate the manufacturer in correlating the amount or frequency of its donations with the number of subsidized prescriptions for its products.111657.12. The department shall enforce a violation of this article only upon receipt of a complaint that alleges that violation.SEC. 2. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
The people of the State of California do enact as follows:
## The people of the State of California do enact as follows:
SECTION 1. Article 7 (commencing with Section 111657) is added to Chapter 6 of Part 5 of Division 104 of the Health and Safety Code, to read: Article 7. Prescription Drug Discount Prohibition111657. Except as provided in Section 111657.5, a person who manufactures a prescription drug shall not offer in the state a discount, repayment, product voucher, or other reduction in an individuals out-of-pocket expenses associated with his or her insurance coverage, including, but not limited to, a copayment, coinsurance, or deductible, for a prescription drug if a lower cost generic drug is covered under the individuals health plan on a lower cost-sharing tier that is designated to be therapeutically equivalent as indicated by the United States Food and Drug Administrations Approved Drug and Products with Therapeutic Equivalence Evaluations.111657.1. Except as provided in Section 111657.5, a person who manufactures a prescription drug shall not offer in the state a discount, repayment, product voucher, or other reduction in the individuals out-of-pocket expenses associated with his or her insurance coverage, including, but not limited to, a copayment, coinsurance, or deductible, for a prescription drug if the active ingredients of the drug are available without prescription at a lower cost and are not otherwise contraindicated for treatment of the condition for which the prescription drug is approved.111657.5. The prohibitions in Sections 111657 and 111657.1 shall not apply to any of the following:(a) A discount, repayment, product voucher, or other payment to a patient or another person on the patients behalf for a prescription drug required under a United States Food and Drug Administration Risk Evaluation and Mitigation Strategy for the purpose of monitoring or facilitating the use of that prescription drug in a manner consistent with the approved labeling of the prescription drug.(b) A single-tablet drug regimen for treatment or prevention of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) that is as effective as a multitablet regimen, unless, consistent with clinical guidelines and peer-reviewed scientific and medical literature, the multitablet regimen is clinically equally effective or more effective and is more likely to result in adherence to the drug regimen.(c) Rebates received by a state agency.111657.7. This article does not prohibit an entity, including an entity that manufactures prescription drugs, from offering pharmaceutical products free of any cost to both patients and insurers.111657.10. (a) This article shall not be deemed to affect a pharmacists ability to substitute a prescription drug pursuant to Section 4073 of the Business and Professions Code.(b) (1) This article shall not prohibit or limit assistance to a patient provided by an independent charity patient assistance program.(2) For purposes of this section, independent charity patient assistance program means a program that meets all of the following requirements:(A) The program does not allow a pharmaceutical manufacturer or an affiliate of the manufacturer, including, but not limited to, an employee, agent, officer, shareholder, contractor, wholesaler, distributor, or pharmacy benefits manager, to exert any direct or indirect influence or control over the charity or subsidy program.(B) Assistance is awarded in a truly independent manner that severs any link between a pharmaceutical manufacturers funding and the beneficiary.(C) Assistance is awarded without regard to the pharmaceutical manufacturers interest and without regard to the beneficiarys choice of product, provider, practitioner, supplier, or insurance plan.(D) Assistance is awarded based upon a reasonable, verifiable, and uniform measure of financial need that is applied in a consistent manner.(E) The pharmaceutical manufacturer does not solicit or receive data from the program that would facilitate the manufacturer in correlating the amount or frequency of its donations with the number of subsidized prescriptions for its products.111657.12. The department shall enforce a violation of this article only upon receipt of a complaint that alleges that violation.
SECTION 1. Article 7 (commencing with Section 111657) is added to Chapter 6 of Part 5 of Division 104 of the Health and Safety Code, to read:
### SECTION 1.
Article 7. Prescription Drug Discount Prohibition111657. Except as provided in Section 111657.5, a person who manufactures a prescription drug shall not offer in the state a discount, repayment, product voucher, or other reduction in an individuals out-of-pocket expenses associated with his or her insurance coverage, including, but not limited to, a copayment, coinsurance, or deductible, for a prescription drug if a lower cost generic drug is covered under the individuals health plan on a lower cost-sharing tier that is designated to be therapeutically equivalent as indicated by the United States Food and Drug Administrations Approved Drug and Products with Therapeutic Equivalence Evaluations.111657.1. Except as provided in Section 111657.5, a person who manufactures a prescription drug shall not offer in the state a discount, repayment, product voucher, or other reduction in the individuals out-of-pocket expenses associated with his or her insurance coverage, including, but not limited to, a copayment, coinsurance, or deductible, for a prescription drug if the active ingredients of the drug are available without prescription at a lower cost and are not otherwise contraindicated for treatment of the condition for which the prescription drug is approved.111657.5. The prohibitions in Sections 111657 and 111657.1 shall not apply to any of the following:(a) A discount, repayment, product voucher, or other payment to a patient or another person on the patients behalf for a prescription drug required under a United States Food and Drug Administration Risk Evaluation and Mitigation Strategy for the purpose of monitoring or facilitating the use of that prescription drug in a manner consistent with the approved labeling of the prescription drug.(b) A single-tablet drug regimen for treatment or prevention of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) that is as effective as a multitablet regimen, unless, consistent with clinical guidelines and peer-reviewed scientific and medical literature, the multitablet regimen is clinically equally effective or more effective and is more likely to result in adherence to the drug regimen.(c) Rebates received by a state agency.111657.7. This article does not prohibit an entity, including an entity that manufactures prescription drugs, from offering pharmaceutical products free of any cost to both patients and insurers.111657.10. (a) This article shall not be deemed to affect a pharmacists ability to substitute a prescription drug pursuant to Section 4073 of the Business and Professions Code.(b) (1) This article shall not prohibit or limit assistance to a patient provided by an independent charity patient assistance program.(2) For purposes of this section, independent charity patient assistance program means a program that meets all of the following requirements:(A) The program does not allow a pharmaceutical manufacturer or an affiliate of the manufacturer, including, but not limited to, an employee, agent, officer, shareholder, contractor, wholesaler, distributor, or pharmacy benefits manager, to exert any direct or indirect influence or control over the charity or subsidy program.(B) Assistance is awarded in a truly independent manner that severs any link between a pharmaceutical manufacturers funding and the beneficiary.(C) Assistance is awarded without regard to the pharmaceutical manufacturers interest and without regard to the beneficiarys choice of product, provider, practitioner, supplier, or insurance plan.(D) Assistance is awarded based upon a reasonable, verifiable, and uniform measure of financial need that is applied in a consistent manner.(E) The pharmaceutical manufacturer does not solicit or receive data from the program that would facilitate the manufacturer in correlating the amount or frequency of its donations with the number of subsidized prescriptions for its products.111657.12. The department shall enforce a violation of this article only upon receipt of a complaint that alleges that violation.
Article 7. Prescription Drug Discount Prohibition111657. Except as provided in Section 111657.5, a person who manufactures a prescription drug shall not offer in the state a discount, repayment, product voucher, or other reduction in an individuals out-of-pocket expenses associated with his or her insurance coverage, including, but not limited to, a copayment, coinsurance, or deductible, for a prescription drug if a lower cost generic drug is covered under the individuals health plan on a lower cost-sharing tier that is designated to be therapeutically equivalent as indicated by the United States Food and Drug Administrations Approved Drug and Products with Therapeutic Equivalence Evaluations.111657.1. Except as provided in Section 111657.5, a person who manufactures a prescription drug shall not offer in the state a discount, repayment, product voucher, or other reduction in the individuals out-of-pocket expenses associated with his or her insurance coverage, including, but not limited to, a copayment, coinsurance, or deductible, for a prescription drug if the active ingredients of the drug are available without prescription at a lower cost and are not otherwise contraindicated for treatment of the condition for which the prescription drug is approved.111657.5. The prohibitions in Sections 111657 and 111657.1 shall not apply to any of the following:(a) A discount, repayment, product voucher, or other payment to a patient or another person on the patients behalf for a prescription drug required under a United States Food and Drug Administration Risk Evaluation and Mitigation Strategy for the purpose of monitoring or facilitating the use of that prescription drug in a manner consistent with the approved labeling of the prescription drug.(b) A single-tablet drug regimen for treatment or prevention of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) that is as effective as a multitablet regimen, unless, consistent with clinical guidelines and peer-reviewed scientific and medical literature, the multitablet regimen is clinically equally effective or more effective and is more likely to result in adherence to the drug regimen.(c) Rebates received by a state agency.111657.7. This article does not prohibit an entity, including an entity that manufactures prescription drugs, from offering pharmaceutical products free of any cost to both patients and insurers.111657.10. (a) This article shall not be deemed to affect a pharmacists ability to substitute a prescription drug pursuant to Section 4073 of the Business and Professions Code.(b) (1) This article shall not prohibit or limit assistance to a patient provided by an independent charity patient assistance program.(2) For purposes of this section, independent charity patient assistance program means a program that meets all of the following requirements:(A) The program does not allow a pharmaceutical manufacturer or an affiliate of the manufacturer, including, but not limited to, an employee, agent, officer, shareholder, contractor, wholesaler, distributor, or pharmacy benefits manager, to exert any direct or indirect influence or control over the charity or subsidy program.(B) Assistance is awarded in a truly independent manner that severs any link between a pharmaceutical manufacturers funding and the beneficiary.(C) Assistance is awarded without regard to the pharmaceutical manufacturers interest and without regard to the beneficiarys choice of product, provider, practitioner, supplier, or insurance plan.(D) Assistance is awarded based upon a reasonable, verifiable, and uniform measure of financial need that is applied in a consistent manner.(E) The pharmaceutical manufacturer does not solicit or receive data from the program that would facilitate the manufacturer in correlating the amount or frequency of its donations with the number of subsidized prescriptions for its products.111657.12. The department shall enforce a violation of this article only upon receipt of a complaint that alleges that violation.
Article 7. Prescription Drug Discount Prohibition
Article 7. Prescription Drug Discount Prohibition
111657. Except as provided in Section 111657.5, a person who manufactures a prescription drug shall not offer in the state a discount, repayment, product voucher, or other reduction in an individuals out-of-pocket expenses associated with his or her insurance coverage, including, but not limited to, a copayment, coinsurance, or deductible, for a prescription drug if a lower cost generic drug is covered under the individuals health plan on a lower cost-sharing tier that is designated to be therapeutically equivalent as indicated by the United States Food and Drug Administrations Approved Drug and Products with Therapeutic Equivalence Evaluations.
111657. Except as provided in Section 111657.5, a person who manufactures a prescription drug shall not offer in the state a discount, repayment, product voucher, or other reduction in an individuals out-of-pocket expenses associated with his or her insurance coverage, including, but not limited to, a copayment, coinsurance, or deductible, for a prescription drug if a lower cost generic drug is covered under the individuals health plan on a lower cost-sharing tier that is designated to be therapeutically equivalent as indicated by the United States Food and Drug Administrations Approved Drug and Products with Therapeutic Equivalence Evaluations.
111657.1. Except as provided in Section 111657.5, a person who manufactures a prescription drug shall not offer in the state a discount, repayment, product voucher, or other reduction in the individuals out-of-pocket expenses associated with his or her insurance coverage, including, but not limited to, a copayment, coinsurance, or deductible, for a prescription drug if the active ingredients of the drug are available without prescription at a lower cost and are not otherwise contraindicated for treatment of the condition for which the prescription drug is approved.
111657.1. Except as provided in Section 111657.5, a person who manufactures a prescription drug shall not offer in the state a discount, repayment, product voucher, or other reduction in the individuals out-of-pocket expenses associated with his or her insurance coverage, including, but not limited to, a copayment, coinsurance, or deductible, for a prescription drug if the active ingredients of the drug are available without prescription at a lower cost and are not otherwise contraindicated for treatment of the condition for which the prescription drug is approved.
111657.5. The prohibitions in Sections 111657 and 111657.1 shall not apply to any of the following:(a) A discount, repayment, product voucher, or other payment to a patient or another person on the patients behalf for a prescription drug required under a United States Food and Drug Administration Risk Evaluation and Mitigation Strategy for the purpose of monitoring or facilitating the use of that prescription drug in a manner consistent with the approved labeling of the prescription drug.(b) A single-tablet drug regimen for treatment or prevention of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) that is as effective as a multitablet regimen, unless, consistent with clinical guidelines and peer-reviewed scientific and medical literature, the multitablet regimen is clinically equally effective or more effective and is more likely to result in adherence to the drug regimen.(c) Rebates received by a state agency.
111657.5. The prohibitions in Sections 111657 and 111657.1 shall not apply to any of the following:
(a) A discount, repayment, product voucher, or other payment to a patient or another person on the patients behalf for a prescription drug required under a United States Food and Drug Administration Risk Evaluation and Mitigation Strategy for the purpose of monitoring or facilitating the use of that prescription drug in a manner consistent with the approved labeling of the prescription drug.
(b) A single-tablet drug regimen for treatment or prevention of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) that is as effective as a multitablet regimen, unless, consistent with clinical guidelines and peer-reviewed scientific and medical literature, the multitablet regimen is clinically equally effective or more effective and is more likely to result in adherence to the drug regimen.
(c) Rebates received by a state agency.
111657.7. This article does not prohibit an entity, including an entity that manufactures prescription drugs, from offering pharmaceutical products free of any cost to both patients and insurers.
111657.7. This article does not prohibit an entity, including an entity that manufactures prescription drugs, from offering pharmaceutical products free of any cost to both patients and insurers.
111657.10. (a) This article shall not be deemed to affect a pharmacists ability to substitute a prescription drug pursuant to Section 4073 of the Business and Professions Code.(b) (1) This article shall not prohibit or limit assistance to a patient provided by an independent charity patient assistance program.(2) For purposes of this section, independent charity patient assistance program means a program that meets all of the following requirements:(A) The program does not allow a pharmaceutical manufacturer or an affiliate of the manufacturer, including, but not limited to, an employee, agent, officer, shareholder, contractor, wholesaler, distributor, or pharmacy benefits manager, to exert any direct or indirect influence or control over the charity or subsidy program.(B) Assistance is awarded in a truly independent manner that severs any link between a pharmaceutical manufacturers funding and the beneficiary.(C) Assistance is awarded without regard to the pharmaceutical manufacturers interest and without regard to the beneficiarys choice of product, provider, practitioner, supplier, or insurance plan.(D) Assistance is awarded based upon a reasonable, verifiable, and uniform measure of financial need that is applied in a consistent manner.(E) The pharmaceutical manufacturer does not solicit or receive data from the program that would facilitate the manufacturer in correlating the amount or frequency of its donations with the number of subsidized prescriptions for its products.
111657.10. (a) This article shall not be deemed to affect a pharmacists ability to substitute a prescription drug pursuant to Section 4073 of the Business and Professions Code.
(b) (1) This article shall not prohibit or limit assistance to a patient provided by an independent charity patient assistance program.
(2) For purposes of this section, independent charity patient assistance program means a program that meets all of the following requirements:
(A) The program does not allow a pharmaceutical manufacturer or an affiliate of the manufacturer, including, but not limited to, an employee, agent, officer, shareholder, contractor, wholesaler, distributor, or pharmacy benefits manager, to exert any direct or indirect influence or control over the charity or subsidy program.
(B) Assistance is awarded in a truly independent manner that severs any link between a pharmaceutical manufacturers funding and the beneficiary.
(C) Assistance is awarded without regard to the pharmaceutical manufacturers interest and without regard to the beneficiarys choice of product, provider, practitioner, supplier, or insurance plan.
(D) Assistance is awarded based upon a reasonable, verifiable, and uniform measure of financial need that is applied in a consistent manner.
(E) The pharmaceutical manufacturer does not solicit or receive data from the program that would facilitate the manufacturer in correlating the amount or frequency of its donations with the number of subsidized prescriptions for its products.
111657.12. The department shall enforce a violation of this article only upon receipt of a complaint that alleges that violation.
111657.12. The department shall enforce a violation of this article only upon receipt of a complaint that alleges that violation.
SEC. 2. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
SEC. 2. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
SEC. 2. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
### SEC. 2.